Study of Bimatoprost Solution in Increasing Eyelash Prominence in African Americans With Eyelash Hypotrichosis

Phase 4

Completed

• Conditions: Hypotrichosis
• Interventions: Drug: bimatoprost ophthalmic 0.03% solution; Drug: vehicle sterile solution (placebo)

• Registration Number: NCT00958035
• Lead Sponsor: Allergan

Brief Summary

This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily to the upper eyelid margins (where the eyelashes meet the skin) compared with vehicle in increasing overall eyelash prominence in self-identified African American/ethnic black subjects exhibiting hypotrichosis of the eyelashes (inadequate or not enough eyelashes).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-11
• Study First Submitted QC: 2009-08-12
• Study First Posted: 2009-08-13
• Study Start: 2009-11
• Primary Completion: 2010-07
• Study Completion: 2010-08
• Status Verified: 2011-11
• Results First Submitted: 2011-11-30
• Results First Submitted QC: 2011-11-30
• Last Update Submitted: 2011-11-30
• Results First Posted: 2012-01-05
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• African American/ethnic black
• Adults at least 18 years of age
• Eyelash prominence assessment of minimal or moderate

Exclusion Criteria

• Subjects with uneven lashes or longer on one side than the other
• Any eye disease or abnormality
• Eye surgery
• Severe hyperpigmentation around the eye
• Eyelash implants
• Eyelash extension application
• Any use of eyelash growth products within 6 months
• Any use of prescription eyelash growth products
• Treatments that may affect hair growth
• Requiring eye drop medications for glaucoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LATISSE®	bimatoprost ophthalmic 0.03% solution	bimatoprost ophthalmic 0.03% solution
Placebo	vehicle sterile solution (placebo)	vehicle sterile solution

Primary Outcome Measures

Name	Time	Method
Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4	Month 4	Percentage of treatment responders in overall eyelash prominence, defined as at least a 1-grade improvement from baseline at Month 4 in the Global Eyelash Assessment (GEA) Scale. The GEA is a 4-point scale in which eyelash prominence is assessed from 1 (minimal prominence) to 4 (very marked prominence).